The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.

The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining asseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.

Device Description

The Chemo-Spike II Reconstitution Devices has been designed for preparing and dispensing lyophilized chemotherapy drugs in vials. The device offers a sterile vent pathway, filtering the air, as well as a filtered pathway for the actual diluent or medication. The sterile vent protects the health care practitioner by releasing the vacuum from the drug vials during reconstitution with diluent. It also protects the patient by filtering microprecipitates and crystallizations. from the diluent after reconstitution.

The Chemo-Spike II Reconstitution Device consists of 2 filter media, a 5 micron hydrophilic filter for the actual medication (i.e. fluid) pathway and a 0.2 micron hydrophobic filter for venting the air pathway. Both filters are manufactured from PTFE (polytetrafluoroethylene) membrane and are housed in molded acrylic. The effective filtration area for the medication measures 1.0 cm2 while the effective vent area measures 4.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.

The Dispensing-Spike II has been designed for preparing and dispensing multiple dose I.V. medication stored in rubber-stoppered vials. It is equipped with a sharp piercing spike and tight luer lock port with a hinged cap. The technician pierces the medication vial just once with the spike. A syringe, without a needle, should be affixed to the luer lock port. Repetitive injections into or aspirations from the multiple dose I.V. vial are made through the port of the spike device. This reduces the number of times the diaphragm of the vial is pierced.

The Dispensing-Spike II is equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway. The sterile vent protects the health care practitioner by helping to release the vacuum from the drug vials during reconstitution with diluent.

The Dispensing-Spike II is manufactured from PTFE (mentioned above) and molded acrylic. The effective filtration area measures 1.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.

AI/ML Overview

The provided documents describe two devices, the "Chemo-Spike II Reconstitution Device" and the "Dispensing-Spike II Device," and their 510(k) submissions to the FDA. However, these documents do not contain any information regarding specific acceptance criteria, device performance studies, or the methodologies typically associated with assessing the performance of AI/ML-based medical devices (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies).

These devices are physical medical accessories (a reconstitution device and a dispensing spike) designed for preparing and dispensing medications, primarily by filtering air and diluent/medication. The FDA review for these types of devices focuses on substantial equivalence to predicate devices, biocompatibility (USP Class VI Plastics testing), and sterility, rather than statistical performance metrics like sensitivity, specificity, or accuracy for diagnostic algorithms.

Therefore, I cannot provide the requested information for acceptance criteria and study details as it pertains to AI/ML device evaluation. The information below reflects what can be extracted from the provided text, which is limited to the device's function and a general statement about its safety and effectiveness relative to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

Based on the provided documents, explicit quantitative acceptance criteria and reported device performance in the context of diagnostic or AI/ML evaluations are not available. The device's "performance" is implicitly tied to its functional description and the assertion of "no new issues of safety and effectiveness" compared to predicate devices.

Acceptance Criterion (Implicit based on device type)	Reported Device Performance (as stated in documents)
Chemo-Spike II Reconstitution Device:
Sterile Vent Pathway Functionality	Provides a sterile vent pathway, filtering air (0.2 micron hydrophobic filter) to protect healthcare practitioners and patients.
Medication Pathway Filtration	Filters microprecipitates and crystallizations from diluent/medication (5 micron hydrophilic filter) to protect patients.
Biocompatibility	USP Class VI Plastics testing conducted and found to be biosafe.
Dispensing-Spike II Device:
Sterile Vent Pathway Functionality	Equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway, protecting healthcare practitioners.
Reduction of Vial Piercings	Reduces the number of times the diaphragm of the vial is pierced for multiple-dose IV medication preparation.
Biocompatibility	USP Class VI Plastics testing conducted and found to be biosafe.
Substantial Equivalence to Predicate	Designed to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness.
Sterilization and Packaging (Dispensing-Spike II only)	The only change from the predicate is the method of sterilization and packaging, implying it meets previous sterilization efficacy.

The following sections (2-9) are not applicable to the provided documents as they describe physical medical accessories and their 510(k) clearances, which do not involve AI/ML performance studies or ground truth establishment in the manner typically required for such algorithms.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The documents do not describe performance studies involving test datasets for AI/ML algorithms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for diagnostic applications is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or ground truth adjudication described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. These are not AI-assisted devices for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth for diagnostic purposes is relevant to these devices.

8. The sample size for the training set

Not applicable. No training sets for AI/ML algorithms are mentioned.

9. How the ground truth for the training set was established

Not applicable. No training sets or ground truth establishment process is described.

Summary

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PRODUCTS AND SYSTEMS FOR THE HEALTH CARE COMPLEX

Mailing Unlimited EXTEM-PREP™ SYSTEMS PS® Inc. Modi-Date® Inc. Summary of Safety and Effectiveness

JAN - 8 1998

Chemo-Spike® II Reconstitution Device Name of Device:

Catalog Number: IV5002

Classification: Chemo Dispensing/Mixing accessories would most likely have been reviewed by the FDA General Hospital Panel, Code 80, product code assignment 80FMF. This product would most likely be categorized as an accessory to a syringe, according to 21 CFR 880.5860.

Summary Statement

The Chemo-Spike II Reconstitution Device is the predicate device granted 510(k) #K941020, manufactured by Gelman Sciences, Inc. Gelman Sciences, Inc. is the actual subcontractor of this product. The Chemo-Spike II Reconstitution Device is to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness.

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PRODUCTS AND SYSTEMS FOR THE HEALTH CARE COMPLEX

EXTEM-PREP™ SYSTEMS Mailing Unlimited Summary of Safety and Effectiveness

Dispensing-Spike II Device Name of Device:

IV2052 Catalog Number:

Classification: I.V. Dispensing/Mixing accessories would most likely have been reviewed by the FDA General Hospital Panel, Code 80, product code assignment 80FMF. This product would most likely be categorized as an accessory to a syringe, according to 21 CFR 880.5860.

Summary Statement

Please note that this product has been granted 510(k) #K946190 to Gelman Sciences, Inc. of Ann Arbor, MI. Gelman Sciences is the actual subcontractor of this product. The only change between the Gelman Sciences product and the EPS product described above is the method of sterilization and packaging.

The Dispensing-Spike II Device is the predicate device granted 510(k) #K946190, manufactured by Gelman Sciences, Inc. Gelman Sciences, Inc. is the actual subcontractor of this product. The Dispensing-Spike Device is to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the perimeter of the circle. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Braverman Director of Marketing Medi-Dose, Incorporated 1671 Loretta Avenue Feasterville, Pennsylvania 19053

JAN - 8 -

Re : K974431 Trade Name: Chemo-Spike II Reconstitution Device Requlatory Class: II Product Code: IHI Dated: November 22, 1997 Received: November 24, 1997

Dear Mr. Braverman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Braverman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Clatrust

Tim thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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P.02
.

. Page / of /

510(k) Number (if known): K974431

Device Name: CHEMO-SPIKE II RECONSTITUTION DEVICE
DISPENSING SPIAE II DEVICE

Indications For Use:

Indication for Use of Chem

The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and I no oneing of lyophilized chemotherapy drugs in multiple dose visis. The device is used to cither add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.

Indication for Use of Dispensing-Spike II Device

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Crescenti
(Division Sign-Off)

Division of Dental, Infection C and General Hospital D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.